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Infusion Pump
EUDAMEDClass IIb (EU MDR)
Ref BioFusion P500 ExModel BioFusion S500Ref BioFusion S500 NeoRef BioFusion S500 ExRef BioFusion P500Ref CODAN 907 VRef BioFusion P500 ProRef BioFusion P500 Neo
Identity
- Trade Name
- Infusion Pump EUDAMED
- Device Name
- Infusion Pump EUDAMED
- Model / Reference
- BioFusion S500 EUDAMEDBioFusion P500 Ex EUDAMEDBioFusion S500 Neo EUDAMEDBioFusion S500 Ex EUDAMEDBioFusion P500 EUDAMEDCODAN 907 V EUDAMEDBioFusion P500 Pro EUDAMEDBioFusion P500 Neo EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932562301797 EUDAMED06932562301117 EUDAMED06932562301124 EUDAMED06932562301766 EUDAMED06932562301100 EUDAMED06932562301933 EUDAMED06932562301773 EUDAMED06932562301780 EUDAMED
- Basic UDI-DI
- 69325623300034K EUDAMED
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infusion Pump by Guangdong Biolight Meditech Co., Ltd — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69325623300034K | Class IIb | Active |
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Manufacturer
- Manufacturer
- Guangdong Biolight Meditech Co., Ltd
- EUDAMED SRN
- CN-MF-000006333
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (8)
- EUDAMED 282b7721-f812-4e24-8e18-268b231ae73e 61 fields · synced Jul 29, 2026
- EUDAMED 3d61a054-5dfa-461e-b3d9-909b2a3a359b 61 fields · synced May 17, 2026
- EUDAMED a4f09af7-01c0-4d51-bccf-cca2aae451b7 61 fields · synced May 17, 2026
- EUDAMED 97f5b9c0-8690-4ffa-9a08-cb6a208195d6 61 fields · synced May 18, 2026
- EUDAMED ea4c96a9-6674-4cce-a748-304ce0b5783d 61 fields · synced May 18, 2026
- EUDAMED bb34c33f-175d-4850-a0c5-0ec4e04056df 61 fields · synced May 18, 2026
- EUDAMED 18f43b80-8390-4aec-a635-3771d6c1db65 61 fields · synced May 18, 2026
- EUDAMED 0f92e296-05ce-4ec8-9a2f-44d92725f5cb 61 fields · synced May 19, 2026